Tonix Pharmaceuticals Promotes Siobhan Fogarty to Chief Technical Officer Ms. Fogarty has served at Tonix since 2016, most recently as Executive Vice President, Product Development Tonix is Preparing for Potential Launch

TONIX PHARMACEUTICALS HOLDING CORP. 8-K

Tonix Pharmaceuticals Promotes Siobhan Fogarty

to Chief Technical Officer

Ms. Fogarty has served at Tonix since 2016,

most recently as Executive Vice President, Product Development

Tonix is Preparing for Potential Launch of

TNX-102 SL for the management of fibromyalgia with U.S. FDA PDUFA goal date of August 15, 2025

CHATHAM, N.J., February 4, 2025 (GLOBE NEWSWIRE)

- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a fully-integrated biopharmaceutical company with marketed

products and a pipeline of development candidates, today announced the promotion of Siobhan Fogarty to Chief Technical Officer (CTO),

effective immediately. Ms. Fogarty joined Tonix in 2016 and previously served as Executive Vice President of Product Development. Ms.

Fogarty has over 25 years of experience in pharmaceutical and biotech product development, manufacturing and quality, for both small and

large molecules, at notable pharmaceutical and biotech companies.

In December, Tonix announced that the U.S.

Food and Drug Administration (FDA) assigned a Prescription Drug User Fee Act (PDUFA) goal date of August 15, 2025, for a decision on marketing

authorization for TNX-102 SL (cyclobenzaprine HCl sublingual tablets) 5.6 mg for the management of fibromyalgia. TNX-102 SL is a non-opioid,

centrally-acting analgesic. Fibromyalgia is a common chronic pain condition that affects mostly women.

"Siobhan is an invaluable member of

our team and an outstanding leader who has contributed in many ways to our success since she joined in 2016, and we are excited that she

is executing at a higher level in her new role as our first CTO," said Seth Lederman, M.D., President and Chief Executive Officer

of Tonix Pharmaceuticals. "Her energy, insights and organizational abilities will be welcome as we enter into a landmark time for

the Company with the upcoming PDUFA goal date of August 15, 2025, for TNX-102 SL for the management of fibromyalgia. In addition to her

stewardship of TNX-102 SL, Siobhan has played key roles advancing our pipeline of small molecule, biologics and live-virus vaccines."

Ms. Fogarty started her career with Elan Corporation

as a formulation scientist where she gained experience in several different areas of drug delivery, including solid, liquids, IV, and

transdermal formulations. At Elan, she took products from concept to commercial manufacture in both Ireland and the U.S. Ms. Fogarty moved

to Glaxo SmithKline, London, as a manufacturing strategist after the merger of Glaxo and SmithKline Beecham. Returning to product development,

Ms. Fogarty established European product development sites for Fuisz Technologies and Biovail Corporation, leading multi-disciplinary

teams for the development of products from early conceptual/preclinical development, through the various clinical phases and transferring

to U.S./Canadian manufacturing sites during registration for commercialization. Subsequently, Ms. Fogarty started a consultancy firm,

eMSc, that advised pharmaceutical and biotech companies in product development and implementation of a phased approach to quality. Ms.

Fogarty obtained her masters in Pharmaceutical Sciences at Trinity College, Dublin, and is a European Union Qualified Person. Her primary

degree is in Industrial Chemistry from the University of Limerick where she interned at Pfizer.

"I am grateful for the incredible eight

years I have already enjoyed working at Tonix and look forward to the challenges and opportunities of my new role," said Ms. Fogarty.

"Tonix is entering a momentous time, and it is an honor to assume these new responsibilities as part of this extraordinary team."

Tonix Pharmaceuticals Holding Corp.*

Tonix is a fully integrated biopharmaceutical

company focused on transforming therapies for pain management and vaccines for public health challenges. Tonix's development portfolio

is focused on central nervous system (CNS) disorders. Tonix's priority is to advance TNX-102 SL, a product candidate for the management

of fibromyalgia, for which an NDA was submitted based on two statistically significant Phase 3 studies for the management of fibromyalgia

and for which a PDUFA (Prescription Drug User Fee act) goal date of August 15, 2025 has been assigned for a decision on marketing authorization.

The FDA has also granted Fast Track designation to TNX-102 SL for the management of fibromyalgia. TNX-102 SL is also being developed to

treat acute stress reaction and acute stress disorder under a Physician-Initiated IND at the University of North Carolina in the OASIS

study funded by the U.S. Department of Defense (DoD). Tonix's CNS portfolio includes TNX-1300 (cocaine esterase), a biologic in

Phase 2 development designed to treat cocaine intoxication that has FDA Breakthrough Therapy designation, and its development is supported

by a grant from the National Institute on Drug Abuse. Tonix's immunology development portfolio consists of biologics to address

organ transplant rejection, autoimmunity and cancer, including TNX-1500, which is an Fc-modified humanized monoclonal antibody targeting

CD40-ligand (CD40L or CD154) being developed for the prevention of allograft rejection and for the treatment of autoimmune diseases. Tonix

also has product candidates in development in the area of infectious disease, including a vaccine for mpox, TNX-801. Tonix recently announced

a contract with the U.S. DoD's Defense Threat Reduction Agency (DTRA) for up to $34 million over five years to develop TNX-4200,

small molecule broad-spectrum antiviral agents targeting CD45 for the prevention or treatment of infections to improve the medical readiness

of military personnel in biological threat environments. Tonix owns and operates a state-of-the art infectious disease research facility

in Frederick, Md. Tonix Medicines, our commercial subsidiary, markets Zembrace SymTouch (sumatriptan injection) 3 mg and Tosymra

(sumatriptan nasal spray) 10 mg for the treatment of acute migraine with or without aura in adults.

* Tonix's product development candidates are

investigational new drugs or biologics; their efficacy and safety have not been established and have not been approved for any indication.

Zembrace SymTouch and Tosymra are registered trademarks

of Tonix Medicines. All other marks are property of their respective owners.

This press release and further information about

Tonix can be found at www.tonixpharma.com.

Forward Looking Statements

Certain statements in this press release

are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified

by the use of forward-looking words such as "anticipate," "believe," "forecast,"

"estimate," "expect," and "intend," among others. These forward-looking statements are based on

Tonix's current expectations and actual results could differ materially. There are a number of factors that could cause actual

events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to,

risks related to the failure to obtain FDA clearances or approvals and noncompliance with FDA regulations; risks related to the

failure to successfully market any of our products; risks related to the timing and progress of clinical development of our product

candidates; our need for additional financing; uncertainties of patent protection and litigation; uncertainties of government or

third party payor reimbursement; limited research and development efforts and dependence upon third parties; and substantial

competition. As with any pharmaceutical under development, there are significant risks in the development, regulatory approval and

commercialization of new products. Tonix does not undertake an obligation to update or revise any forward-looking statement.

Investors should read the risk factors set forth in the Annual Report on Form 10-K for the year ended December 31, 2023, as filed

with the Securities and Exchange Commission (the "SEC") on April 1, 2024, and periodic reports filed with the SEC on or

after the date thereof. All of Tonix's forward-looking statements are expressly qualified by all such risk factors and other

cautionary statements. The information set forth herein speaks only as of the date thereof.

Tonix Pharmaceuticals

Indication and Usage

Zembrace SymTouch (sumatriptan succinate) injection (Zembrace)

and Tosymra (sumatriptan) nasal spray are prescription medicines used to treat acute migraine headaches with or without aura in adults

who have been diagnosed with migraine.

Zembrace and Tosymra are not used to prevent migraines. It is not

known if Zembrace or Tosymra are safe and effective in children under 18 years of age.

Important Safety Information

Zembrace and Tosymra can cause serious side effects, including

heart attack and other heart problems, which may lead to death. Stop use and get emergency help if you have any signs of a heart attack:

Zembrace and Tosymra are not for people with risk factors for heart

disease (high blood pressure or cholesterol, smoking, overweight, diabetes, family history of heart disease) unless a heart exam shows

Do not use Zembrace or Tosymra if you have:

Tell your provider about all of your medical conditions and medicines

you take, including vitamins and supplements.

Zembrace and Tosymra can cause dizziness, weakness, or drowsiness.

If so, do not drive a car, use machinery, or do anything where you need to be alert.

Zembrace and Tosymra may cause serious side effects including:

The most common side effects of Zembrace and Tosymra include: pain